Health Canada — Medical Devices · Canada · 2024-03-07 · Type II
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Reported risk: During testing it was found that one of the batches, had an insufficient concentration of sodium pyruvate - only 0.002 mg/ml compared to a specified concentration of 0.046-0.137 mg/ml (1.5-4.3% of the specified amount). Part of this formulation batch had also been used to create three lots of commercially released sperm wash medium. Recall start date: January 22, 2024
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